Kornimate/medical-research-clean huggingface dataset:
flat and circadian insulin infusion rates in continuous subcutaneous insulin infusion

Conditions: Type 1 Diabetes

Summary: randomised controlled trial to contribute to the evidence base for the optimal initial insulin profile for adults with type 1 diabetes commencing insulin pump therapy.

initiation of insulin pump therapy in people with type 1 diabetes requires conversion of a basal insulin dose, given as once or twice daily long-acting insulin, to a continuous basal infusion regimen. this conversion may be based on basal insulin dose only, or total daily insulin dose, and may result in a flat basal insulin profile or an initial variable basal rate. initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years. initial rates were developed from 63 well-controlled people with type 1 diabetes over 14 years of age and have been assessed against a flat basal rate in a small randomised controlled trial with 12 participants. mean glucose was lower in the circadian basal rate group with particular differences noted in the early morning when glucose rises were more pronounced in the flat basal rate group1. in 50 people with type 1 diabetes treated with insulin pump therapy, hba1c was lower in those with lower basal rates at midnight, and in those with higher basal rates in the afternoon, suggesting a benefit of circadian patterns2. in 33 people with type 1 diabetes over 16 years of age basal rate distribution established at commencement of pump therapy did not alter over 6 months3. however, a 6 month cross-over study of circadian rates and oligophasic basal rates showed no difference in hba1c4. following initiation on insulin pump therapy basal rates are personalised to capillary blood and continuous interstitial fluid glucose monitoring. in adults with type 1 diabetes starting insulin pump therapy there are limited data to guide the optimal insulin profile to rapidly achieve target glucose and minimise healthcare professional input.

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * diagnosis of t1dm for \> 1 year * on mdi with decision made to commence csii * structured education in previous 3 years * hba1c ≤ 75mmol/mol (9%) * stimulated c-peptide \<200pmol/l * no severe hypoglycaemia (defined as needing 3rd party assistance) in previous year exclusion criteria: * previous csii * night or shift worker * recurrent severe hypoglycaemia * pregnant or planning pregnancy * breastfeeding * enrolled in other clinical trials * have active malignancy or under investigation for malignancy * addison's disease * gastroparesis * autonomic neuropathy * concomitant use of glp-1 analogues and gliptins * visual impairment * reduced manual dexterity
oral deforolimus with trastuzumab for patients with her2-positive trastuzumab-refractory metastatic breast cancer (8669-009)

Conditions: Breast Cancer; Breast Neoplasms

Summary: this clinical trial will study the use of ridaforolimus in metastatic breast cancer subjects whose tumors have shown a resistance to trastuzumab (herceptin). the goal of this study is to find out if subjects treated with ridaforolimus in combination with trastuzumab have a positive response to the treatment, and if treatment with ridaforolimus in combination with trastuzumab prolongs survival.


Eligibility criteria:
inclusion criteria: * female, 18 years of age or older * histologically confirmed her2-positive metastatic breast cancer * trastuzumab-resistance * measurable disease, according to recist guidelines * ecog performance status less than or equal to 1 * life expectancy greater than 3 months * no prior treatment with temsirolimus, everolimus, rapamycin, or any other mtor inhibitor * at least 4 weeks must have lapsed between prior investigational therapy, chemotherapy or radiotherapy, and the first dose of ridaforolimus * left ventricular ejection greater than or equal to 50% * adequate cardiovascular function * adequate hematological, hepatic, and renal function * serum cholesterol less than or equal to 350 mg/dl and triglycerides less than or equal to 400 mg/dl * negative pregnancy test within 7 days prior to first dose of study drug and must use an approved contraceptive method from screening to 30 days after the last dose of study drug * availability and patient consent to obtain archival tissue samples * signed informed consent exclusion criteria: * inadequate recovery from any prior surgical procedure or having undergone any major surgery within 2 weeks before trial entry * grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy if these reactions prevented further trastuzumab administration * grade 3 or grade 4 hypersensitivity reaction to prior trastuzumab * symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest * known allergy to macrolide antibiotics * pregnant or breast-feeding * know history of hiv * diagnosis of brain metastasis or leptomeningeal carcinomatosis within 3 months * other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin * active infection requiring prescription intervention * newly diagnosed or poorly controlled type 1 or 2 diabetes * other concurrent illness which, in the investigator's judgment, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug * concurrent treatment with medications that strongly induce or inhibit cytochrome p450. * any condition that renders patient unable to fully understand and provide informed consent and/or comply with the protocol

Keywords: ridaforolimus deforolimus ap23573 breast cancer
flexible ureteroscopy versus mini-percutaneous nephrolithotomy for treatment of renal stones

Conditions: Stone;Renal

Summary: management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (eswl), flexible ureteroscopy (f-urs) and miniaturised percutaneous nephrolithotomy (mini-pcnl). despite being the only truly-non-invasive, outpatient procedure, stone-free rates (sfrs) of eswl are lower than both mini-pcnl and f-urs. furthermore, eswl has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (\>2cm); stones with high densities (\>970/1000 hounsfield units); eswl-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; morbidities of the conventional pcnl are significantly minimised by using less access diameters in pcnl while providing comparable sfrs. additionally, mini and micro pcnl result in shorter hospital stay and higher tubeless rates compared to conventional pcnl. flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than pcnl and mini-pcnl in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. additionally, f-urs is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. nevertheless, its poor durability and high costs remain major limitations for f-urs, especially in developing countries.


Eligibility criteria:
inclusion criteria: 1. age above than 15 years 2. renal stone(s) with total burden of 2 cm or less 3. signature on written, informed consents with the details of this study requirements. 4. inappropriateness or failure of eswl (examples of eswl inappropriateness: patient preference; distal obstruction; contraindications of eswl) exclusion criteria: 1- asymptomatic bacteruria 2- active urinary tract infection (uti) 3- uncorrected coagulopathy 4- current use of antiplatelet therapy 5- pregnancy -
prevalence of germline gene mutations in patients with myeloproliferative neoplasms with family history

Conditions: Polycythemia Vera; Essential Thrombocythaemia; Myelofibrosis

Summary: philadelphia-negative myeloproliferative neoplasms (mpns) occur sporadically and are due to somatic mutations in the jak2 (janus kinase 2), calr (calreticulin) and mpl (thrombopoietin receptor) genes. however, data from epidemiological and family studies clearly highlight a heritable component that influences the risk of developing mpn and potentially contributes to the observed phenotypic pleiotropy. genome-wide association studies in mpn familial clusters have identified a number of germline genetic variants associated with an increased risk of developing mpn. the strongest association discovered so far is the presence of the jak2 46/1 haplotype and, subsequently, several studies have found additional variants in other genes, particularly in the tert gene. the aim of the study would be to investigate the presence of germline mutations in mpn patients selected on the basis of a family history of myeloid neoplasms through the analysis of both already recognized genes and other potentially implicated ones.


Eligibility criteria:
inclusion criteria: \*patients \>18 years * diagnosis of mpn (essential thrombocythemia, polycythemia vera, myelofibrosis) confirmed according to icc 2022 criteria * familiarity for myeloid neoplasia: at least one first or second degree relative affected by myeloid neoplasia (probands) or presence of matching criteria with a proband (controls). each center will be able to contribute with its own available patients/relatives, providing the clinical-laboratory data required by the study. * signing of informed consent according to ich/eu/gcp and local national laws (if applicable) exclusion criteria: * patients \<18 years patients with other hematological diagnoses; • lack of informed consen
neoadjuvant camrelizumab and fluzoparib and nab-paclitaxel in early breast cancer with hrr gene mutation

Conditions: Her-2 Negative Breast Cancer; HRR Gene Mutation

Summary: this study is to evaluate the efficacy and safety of combination of camrelizumab (immunotherapy, pd-1 inhibitor), fluzoparib (parp inhibitor) and nab-paclitaxel in neoadjuvant therapy of her-2 negative breast cancer patients with hrr gene mutation.

this is a prospective, single-center, open-label phase ii clinical trial investigating the activity of camrelizumab+fluzoparib+nab-paclitaxel combination therapy in breast cancer patients with her2-negative and hrr gene mutation for neoadjuvant therapy. anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of nab-paclitaxel (260mg/m2) every 3 weeks, which will add camrelizumab (200mg, d1) and fluzoparib (100mg bid) from the second cycle. hrr gene mutation contains at least one pathogenic or likely pathogenic variant in germline or somatic brca1, bcra2 and palb2 genes, or in germline atm, bard1, brip1, cdk12, chek2, rad51c, rad51d genes.

Eligibility criteria:
inclusion criteria: * histologically documented her-2 negative * tnm stage: t1c, n1-n2；t2-4, n0-n2；any t, n3 * no distant metastatic disease * eastern cooperative oncology group performance status: 0\~1 * hrr gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic brca1, bcra2 and palb2 genes, or in germline atm, bard1, brip1, cdk12, chek2, rad51c, rad51d genes. exclusion criteria: * patients who are pregnant or lactating at the time of randomization or refuse to contraception. * patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ * patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study. * patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease. * patients who have used immunosuppressive drug or corticosteroids within 14 days. * patients who have other diseases which researchers. * patients who allergy to any of the drugs in this trail.
closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip < 6 months

Conditions: Developmental Dislocation of the Hip; Reduction Deformity of Limb

Summary: the purpose of this study is to compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip \< 6 months

we treated children (\<6 months) with prolonged traction before an attempted closed reduction. and compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip. all the patients were followed up for a minimum of 18 months in order to identify any avascular changes in the femoral head. the presence of avascular necrosis was assessed by the criteria of salter.

Eligibility criteria:
inclusion criteria: * the patients with grafⅲ/ⅳtype ddh diagnosed by ultrasound or if they were ihdi (international hip dysplasia institute) grade iii or iv on radiographs，and the infants who were \<6 months of age. patients were followed for at least 18 months,by which time they had either completed treatment with no evidence of requiring further treatment or were treated surgically after failing brace treatment. exclusion criteria: * infants were excluded if they had multiple congenital abnormalities, had prior treatment in other centres, or showed teratological dislocations. the last were defined as fixed dislocation of the hip in association with either a recognised syndrome or a neurological disorder.
the effect of progressive relaxation exercise performed before coronary angiography

Conditions: Coronary Angiography; Progressive Relaxation Exercise; Nursing

Summary: this study was planned to examine the effects of progressive relaxation exercise on anxiety, comfort, pain and physiological parameters in patients undergoing coronary angiography. the data of the study will be collected using the descriptive characteristics questionnaire form, state and trait anxiety inventory, perianesthesia comfort questionnaire, visual analog scale (vas), vital signs follow-up form, complication follow-up form and progressive relaxation exercise application guidelines.

this study was planned to examine the effects of progressive relaxation exercise on anxiety, comfort, pain and physiological parameters in patients undergoing coronary angiography. the data of the study will be collected using the descriptive characteristics questionnaire form, state and trait anxiety inventory, perianesthesia comfort questionnaire, visual analog scale (vas), vital signs follow-up form, complication follow-up form and progressive relaxation exercise application guidelines. patients in the intervention group will undergo progressive relaxation before undergoing angiography. standard practices of the clinic will be applied to the control group.

Eligibility criteria:
inclusion criteria: * patients who can speak and understand turkish, * are over 18 years old, * have space and time orientation, * will undergo coronary angiography for the first time, * do not have any psychiatric illness, * do not have vision or hearing problems, * volunteer to participate in the study will be included. exclusion criteria: * patients who experience any pain or have chronic pain before coronary angiography, * patients who use antihistamines and psychiatric medications, * patients who do not volunteer to participate in the study, * patients who have undergone orthopedic surgery or have any medically diagnosed health problems (orthopedic, neurological, psychological) that prevent relaxation exercises, * patients who have taken sedatives or painkillers up to 5 hours before coronary angiography will not be included in the study.
preserving left colonic artery during radical resection of rectal cancer

Conditions: Postoperative Complications; Proteinosis

Summary: to evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.the investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.

the investigators performed three-dimensional (3d) reconstruction to investigate the vascular anatomy, including the inferior mesenteric artery (ima) and left colic artery (lca),to help make pre-operative strategies of rectal cancer surgery.the investigators will preserving the left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical significance.the investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.

Eligibility criteria:
inclusion criteria: 1. pathological biopsy confirmed adenocarcinoma of the rectum； 2. preoperative assessment of tolerance to surgery without major organ dysfunction； 3. patients must be able to understand and voluntarily sign written informed consent； 4. the surgical method is laparoscopic or robotic anterior rectal cancer resection. exclusion criteria: 1. the patient cannot tolerate the operation； 2. refusal to sign informed consent； 3. patients with distant metastasis of rectal cancer； 4. the surgical method was changed to miles or hartman; 5. unable to complete the follow - up

Keywords: rectal cancer postoperative complications preserve the left colonic artery
low level laser therapy in the dorsal root ganglion in the treatment of chronic low back pain

Conditions: Pain; Low Back Pain; Nociceptive Pain; Neuropathic Pain; Low Level Laser Therapy

Summary: chronic axial low back pain is a public health problem and has a high socioeconomic impact. the dorsal ganglion of the second spinal nerve (gdl2) is a cluster of neuronal bodies responsible for sensory afferent inputs from more than 80% of the lumbar region. low-level laser therapy (lllt) is proven effective to help relieve pain. thus, the aim of this project is to determine the effect of lllt on gdl2 when applied to assist in the diagnosis and treatment of chronic axial low back pain. methodology: 45 patients will be randomized into three groups: laser, radiofrequency and local anesthetic. the patient will be positioned in a prone horizontal position under anesthetic monitoring. the intervertebral foramen between the second and third lumbar vertebrae will be accessed by percutaneous puncture guided by fluoroscopy. in the local anesthetic group, injection of 1 ml lidocaine without vasoconstrictor will be applied in the tubes g20, 150 mm long and 5 mm active tip in contact with the target. in the radiofrequency group, neuromodulation will be held for 300 seconds at 42oc. in the laser group, the laser photon iii® (dcm) will be applied through optic fiber crossing g18 cannulas, during 84 seconds. the pain score will be assessed by visual analog scale. temperature will be measured and aspirate periganglionic sample, trans-operatively, to study interleucins-1β and tnf-alpha assessed by elisa and genetic evaluation trough rna seek, rna isolation and atp quantification. the data will be evaluated for normality and subjected to appropriate statistical analysis, in order to seek representation, as same as the level of significance of the studied samples.


Eligibility criteria:
inclusion criteria: * chronic low back pain (more than 3 months of nociceptive or neuropathic pain). * no neurological deficits exclusion criteria: * active lumbar cancer * active infection * coagulation disorders

Keywords: low level laser therapy low back pain diagnosis genetic clinical trial
urinary neurotrophin levels in healthy children

Conditions: Overactive Bladder

Summary: the aim of this study is to analyse urinary neurotrophin levels in healthy children. urine samples will be collected at 3 different times of day (morning, noon, and evening) at urge sensation from all age groups of children who gained bladder control, i.e. from 3-18 years of age. urinary levels of nerve growth factor (ngf) and brain-derived neurotrophic factor (bdnf) normalised to urinary creatinine will be analysed. age and daytime related variations will be reported for both boys and girls. these results will contribute to understanding the role of neurotrophins in the physiology of lower urinary tract and pathophysiology of idiopathic and secondary hyperactive bladder in children.


Eligibility criteria:
inclusion criteria: * 3-18 years of age * a unremarkable clinical examination * a normal voiding pattern * a minimum of 3 micturitions per day * informed oral and written consent from the child and both parents/legal guardian exclusion criteria: * history of urinary tract infection * diseases of central or peripheral nerve system * anomalies of lumbosacral region * chronic diseases * operative procedures or anomalies of urinary or genital tract * lower urinary tract symptoms * constipation * hypercalcuria * urolithiasis, depression, eating disorders or cardio-metabolic diseases * prior use of anticholinergic treatment

Keywords: neurotrophins nerve growth factor brain-derived neurotrophic factor urinary biomarkers children
remote alcohol monitoring to facilitate abstinence from alcohol: exp 2

Conditions: Alcohol Use Disorder

Summary: directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. as our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. in experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. we will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.


Eligibility criteria:
inclusion criteria: * recently completed or currently completing an alcohol detoxification program through the carilion clinic or university of kentucky healthcare system. * meet dsm-v criteria for alcohol use disorder. * abstinent from alcohol at the time of consent. exclusion criteria: * alcohol use disorder is secondary to another substance use disorder.